Dr. Reddy's Laboratories has announced that the United States Food & Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at its biologics manufacturing facility in Bachupally, Hyderabad.

The inspection, conducted from September 4 to September 12, 2025, resulted in the issuance of a Form 483 with five observations. The company said it is committed to addressing the observations within the stipulated timeline. 

This development follows Dr. Reddy’s recent announcement of completing a definitive transaction with Johnson & Johnson to acquire STUGERON and its locally recognised brands, STUGERON FORTE and STUGERON PLUS, across 18 markets in the APAC and EMEA regions, with India and Vietnam as key markets.

The acquisition represents a strategic opportunity for Dr. Reddy’s to expand its presence in the anti-vertigo segment and strengthen its Central Nervous System (CNS) portfolio.